Clinical Data Management (FDA E6 GCP Guidelines)

Topics

• Best practices for data collection
• Regulatory guidelines for Clinical Data Management
• Responsibilities of personnel
• CDISC/CDASH/STDM standards
• Maintaining confidentiality of data
• Case report form criteria
• Data preparation and quality assurance for accuracy
• Data storage and transferability
• Data systems validation
• Data monitoring plan criteria
• What to expect on a monitoring visit
• Adverse event reporting and coding criteria
• Troubleshooting and resolution of deviations from plan

Who should Attend

Senior attendees involved or interested in:

• Data managers
• Study Investigators
• Statisticians
• Data processors
• Clinical Research Associates
• Site Personnel
• Study Sponsors
• Clinical Project Managers/Leaders
• Staff in the above fields who work with data collection/management and require training in CDM
• Professionals in pharmaceutical, medical device, clinical and biotechnology research who oversee or work with data collection and management
• Compliance auditors and regulatory professionals who require a knowledge of CDM in assessment of study protocols and reports